International safety notice
Alert 2858 (Technosurveillance) - Nipro - Brizio - Membrane Oxygenator and Venous Reservoir with Nipro Integrated Cardiotomy Filter Possibility of liquid leakage during filling of the extracorporeal circulation circuit.
Brazil / Anvisa · BRA · Apr 26, 2019
Key facts
| Title | Alert 2858 (Technosurveillance) - Nipro - Brizio - Membrane Oxygenator and Venous Reservoir with Nipro Integrated Cardiotomy Filter Possibility of liquid leakage during filling of the extracorporeal circulation circuit. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Brizio - Membrane Oxygenator and Venous Reservoir with Nipro Integrated Cardiotomy Filter Technical Name: Oxygenators ANVISA registration number: 10324860078 Risk Class: II Affected model: BRZ+02005A and BRZ+12345A Affected serial numbers: 8C03AR; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO NIPRO MEDICAL LTDA CNPJ 00762455000144 AVENIDA NIPRO 451 REGIÃO NORTE SOROCABA SP TEL 15 32387339 EMAIL MARIANADOURADONIPROCOMBR FABRICANTE DO PRODUTO NIPRO MEDICAL LTDA AVENIDA NIPRO 451 REGIÃO NORTE BRASIL |
| Models | 18I03C, 8C05AR, 18K24BB, 18L09A, 18L06G, 02005A, 19A14C, 18L02BB, 19A05AB, 8J04BB, 18K13EB, 18K09BB and 26 more |
| Date | Apr 26, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1